Linaclotide Drug Class

Side Effects of Linaclotide

Diarrhea is the most common side effect of linaclotide, and it can sometimes be severe.

Diarrhea often begins within the first 2 weeks of linaclotide treatment.

Stop taking linaclotide and call your doctor right away if you get severe diarrhea during treatment with linaclotide.

Other common side effects of linaclotide include:

gas

stomach-area (abdomen) pain

swelling, or a feeling of fullness or pressure in your abdomen (distention)

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of linaclotide. For more information, ask your doctor or pharmacist.

In addition, call your doctor or go to the nearest hospital emergency room right away, if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA­-1088.

Linaclotide Interactions

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Linaclotide Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of linaclotide, there are no specific foods that you must exclude from your diet when receiving this medication.

Linaclotide and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Linaclotide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Linaclotide and Lactation

It is not known if linaclotide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using linaclotide.

The recommended dose of linaclotide for the treatment of chronic idiopathic constipation is 145 mcg taken orally once daily or 72 mcg orally once daily. The dose will be based on symptoms and how well the medication is tolerated.

Linaclotide Overdose

Other Requirements

Store linaclotide at room temperature between 68°F to 77°F (20°C to 25°C).

Keep linaclotide in the bottle that it comes in. The linaclotide bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.

Keep the container of linaclotide tightly closed and in a dry place.

Keep linaclotide and all medicines out of the reach of children.

Linaclotide FDA Warning

Linaclotide is contraindicated in pediatric patients up to 6 years of age. Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.

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